82382 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the comments received. 

During the review process, we may 

consult on an as-needed basis with the 

Health Resources and Services 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by § 486.308(e), the 

following hospital has requested a 

waiver to enter into an agreement with 

a designated OPO other than the OPO 

designated for the service area in which 

the hospital is located: 

Renown South Meadows Medical 

Center d/b/a Renown Rehabilitation 

Hospital, Reno, Nevada, is requesting a 

waiver to work with: 

Nevada Donor Network, Inc., 2055 E 

Sahara Ave., Las Vegas, NV 89104 

The Hospital’s Designated OPO is: 

Donor Network West, 12667 Alcosta 

Blvd. #500, San Ramon, CA 94583 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Comments 

We will consider all comments we 

receive by the date specified in the 

DATES section of this document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: November 17, 2023. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–25904 Filed 11–22–23; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–1370] 

COVID–19: Developing Drugs and 

Biological Products for Treatment or 

Prevention; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘COVID– 

19: Developing Drugs and Biological 

Products for Treatment or Prevention.’’ 

The purpose of this guidance is to assist 

sponsors in the clinical development of 

drugs and biological products for the 

treatment or prevention of COVID–19. 

This guidance describes FDA’s current 

recommendations for phase 2 and phase 

3 trials with a focus on trial population, 

trial design, efficacy endpoints, safety 

considerations, and statistical 

considerations. This guidance 

supersedes the guidance of the same 

name initially issued on May 19, 2020, 

and reissued on February 22, 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 24, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–D–1370 for ‘‘COVID–19: 

Developing Drugs and Biological 

Products for Treatment or Prevention.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 82383 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Maria Clary, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4638, Silver Spring, 

MD 20993–0002, 240–402–8615; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘COVID–19: Developing Drugs and 

Biological Products for Treatment or 

Prevention.’’ This guidance provides 

FDA’s current recommendations for 

phase 2 and phase 3 trials with a focus 

on trial population, trial design, efficacy 

endpoints, safety considerations, and 

statistical considerations. The 

development of drugs for the treatment 

of Long COVID–19, preventative 

vaccines, and convalescent plasma are 

not within the scope of this guidance as 

these development programs raise 

different and additional considerations. 

This guidance supersedes the 

guidance ‘‘COVID–19: Developing Drugs 

and Biological Products for Treatment 

or Prevention,’’ which was initially 

issued on May 19, 2020 (85 FR 29949), 

and subsequently revised and reissued 

on February 22, 2021. This guidance 

was published to support public health 

efforts following a declaration, under 

section 319 of the Public Health Service 

Act (PHS Act) (42 U.S.C. 247d), by the 

Secretary of Health and Human Services 

of a public health emergency related to 

COVID–19. In the Federal Register of 

March 13, 2023 (88 FR 15417) FDA 

listed certain guidance documents that 

FDA was revising to continue in effect 

for 180 days after the expiration of the 

COVID–19 PHE declaration, during 

which time FDA planned to further 

revise the guidances. The February 2021 

guidance on development of drugs and 

biological products for treatment or 

prevention of COVID–19 is included in 

this list. 

FDA is issuing this guidance for 

immediate implementation in 

accordance with our good guidance 

practices regulation (§ 10.115(g)(3) (21 

CFR 10.115(g)(3))) without initially 

seeking prior comment because the 

Agency has determined that prior public 

participation is not feasible or 

appropriate (see § 10.115(g)(2) and 

section 701(h)(1)(C)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

371(h)(1)(C)(i))). Specifically, we are not 

seeking prior comment because 

although the COVID–19-related public 

health emergency declared under 

section 319 of the PHS Act has expired, 

SARS–CoV–2 continues to circulate, 

COVID–19 remains a serious health risk 

for some individuals, and there is a 

need to ensure that sponsors are aware 

of FDA’s recommendations on the 

development of drugs and biological 

products for treatment and prevention 

of COVID–19. This guidance document 

is being implemented immediately, but 

it remains subject to comment in 

accordance with the Agency’s good 

guidance practices. 

FDA considered comments received 

on the guidance and the Agency’s 

experience with COVID–19 drug 

development when making revisions. 

Changes in this final guidance include 

the following: revisions to remove 

reference to the COVID–19 public health 

emergency and updates to the 

recommendations on trial population, 

trial design, efficacy endpoints, safety 

considerations, and statistical 

considerations to reflect the current 

scientific knowledge and state of the 

COVID–19 pandemic. In addition, 

editorial changes were made to improve 

clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘COVID–19: 

Developing Drugs and Biological 

Products for Treatment or Prevention.’’ 

It does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR parts 312 and 

320 have been approved under OMB 

control number 0910–0014. The 

collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

parts 50 and 56 have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR part 601 have been approved under 

OMB control number 0910–0338. The 

collections of information in FDA’s final 

guidance for clinical trial sponsors 

entitled ‘‘Establishment and Operation 

of Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581. The 

collections of information in 42 CFR 

part 11 have been approved under OMB 

control number 0925–0586. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: November 20, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25952 Filed 11–22–23; 8:45 am] 

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